Repurposing Low-Dose Clonidine for PTSD in Veterans

PHASE3RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
PTSDPosttraumatic Stress DisorderSleep
Interventions
DRUG

Clonidine Pill

The study will use a flexible-dose adjustment schedule to identify the minimum dose needed to alleviate symptoms while also ensuring acceptable adverse effects. In other words, all subjects will start at the minimum dose (0.1 mg/night). Near the end of every week, each subject will be assessed for symptom alleviation and adverse events by asking the patient two questions from the CAPS-5 (questions B2 and E6. At baseline, each patient will have scored a ≥3 on each of these questions. If one or both scores remain at ≥3 and if any reported adverse events are marked acceptable by both the clinician and subject, then the dosage for the following week will be increased one level according to the titration chart. However, if both scores for these questions are ≤2 and any current adverse events are acceptable, then the dosage will remain the same. Finally, if any adverse events are deemed unacceptable, the clonidine dosage will be reduced to the lowest acceptable daily dosage.

OTHER

Placebo

Blinded placebo capsules will be provided to participants.

Trial Locations (1)

53213

RECRUITING

Aurora Psychiatric Hospital, Wauwatosa

All Listed Sponsors
lead

Wake Forest University Health Sciences

OTHER